Cleared Traditional

K952535 - ACUFEX ENDOBUTTON TAPE

K952535 is the FDA 510(k) clearance for ACUFEX ENDOBUTTON TAPE by Acufex Microsurgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K952535 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Feb 1996
Decision
252d
Days
Class 2
Risk

K952535 is an FDA 510(k) clearance for the ACUFEX ENDOBUTTON TAPE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K952535 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 01, 1995
Decision Date February 08, 1996
Days to Decision 252 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K952535.
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · United States Surgical, A Division of Tyco Healthc · Apr 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · Smith & Nephew, Inc. · Apr 1998
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993
TI-CRON AND DACRON SUTURES
K930591 · Davis & Geck, Inc. · Dec 1993
MEDSURG MARSHMALLOW TRAY
K920421 · Medsurg Industries, Inc. · Dec 1993